Heweizhixie capsuleTherapy on Patients With Diarrhea

Diarrhea Clinical Trial

Official title:

A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607176
• Other study ID #: ZY3-CCCX-3-1001
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2019
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

Description:

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success

Secondary Outcome Measures:

Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent

Exclusion Criteria:

Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Heweizhixie capsule
3 #, Tid, Oral for 3 days

Locations

Country	Name	City	State
China	Long hua hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with treatment Success	Percent of subjects with treatment Success	3 days
Secondary	Number of unformed stools passed per 24 h period	Number of unformed stools passed per 24 h period	per 24 h period
Secondary	Time (hours) from first intake to the last unformed stools	Time (hours) from first intake to the last unformed stools	3 days
Secondary	Change from baseline of leeds dyspepsia questionnaire score	Change from baseline of leeds dyspepsia questionnaire score	3 days
Secondary	Percent of subjects with AE	Percent of subjects with AE	3 days